A Study to Evaluate the Safety and Efficacy of OT-101+Artemisinin in Hospitalized COVID-19 Subjects

NCT04801017 | Unknown Phase 2

• 1 other identifier: C002 2020 01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective is to evaluate the safety and efficacy of OT-101+Artemisinin when used in combination with standard of care (SoC) in hospitalized COVID 19 subjects versus SoC+ Artemisinin+Placebo.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• The proportion of subjects with clinical improvement score measured by an 8-point WHO COVID-19 Clinical Improvement Ordinal Scale as assessed by the odds ratio (OR) at Day 14.

  Clinical improvement is defined as • A score decrease to categories 1, 2, 3, or 4.

  at Day 14

Secondary Outcomes (10)

• The OR at Days 7, 21, and 28 based on the clinical improvement score (as measured by an 8 point WHO COVID 19 Clinical Improvement Ordinal Scale).

  at Day 7, 21, 28

• The OR at Days 7, 14, 21, and 28 of a decrease of at least 1, 2, 3, and 4 points in subjects with severe COVID 19.

  at Day 7, 14, 21, 28

• Time to at least 2 point improvement from baseline on Days 7, 14, 21, and 28 in subjects with severe COVID 19.

  at Day 7, 14, 21, 28

• Worsening (increase in clinical improvement score) of at least '1' score on Days 7, 14, 21, and 28.

  at Day 7, 14, 21, 28

• Mortality by Days 7, 14, 21, and 28.

  up to Day 28

Other Outcomes (3)

• Incidence of AEs and treatment-emergent AEs (TEAEs).

  up to 28 days

• Adverse events leading to premature discontinuation of the study treatment.

  up to 28 days

• Changes in radiology tests (chest X-ray or chest computed tomography [CT]) from baseline.

  up to 28 days

Study Arms (2)

OT-101 + Artemisinin + Standard of Care

EXPERIMENTAL

OT-101 - Days 1 to 7: 140 mg/m2 daily intravenous (i.v.) infusion for 7 continuous days. Artemisinin: Days 1 to 5: 500 mg per day for 5 days by oral

Drug: OT-101; Drug: Artemisinin

Placebo + Artemisinin + Standard of Care

PLACEBO COMPARATOR

Artemisinin: Days 1 to 5: 500 mg per day for 5 days by oral

Drug: Artemisinin; Drug: Placebo

Interventions

OT-101 DRUG

TGF β2 specific synthetic 18 mer phosphorothioate antisense oligodeoxynucleotide

Also known as: Trabedersen

OT-101 + Artemisinin + Standard of Care

Artemisinin DRUG

Herbal Supplement/ Purified extract from Artemisia

Also known as: ArtiVeda

OT-101 + Artemisinin + Standard of Care; Placebo + Artemisinin + Standard of Care

Placebo DRUG

0.9% sodium chloride injection

Also known as: Normal saline

Placebo + Artemisinin + Standard of Care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized adult male or non-pregnant, non-lactating female subjects (between 18 and 80 years), with SARS-CoV-2 (previously known as 2019-nCoV) infection that is documented by authorized diagnostic PCR test. A rapid PCR test could also be used. Confirmation that subject has COVID-19 within the last 2 weeks prior to randomization.
• Meeting WHO COVID 19 Clinical Improvement Ordinal Scale Criteria 5 (non-invasive mechanical ventilation or high-flow oxygen) or Criteria 6 (intubation and mechanical ventilation).
• O2 sat \<= 93%
• Male subjects and female subjects of childbearing potential must agree to use protocol specified methods of contraception.
• Female subjects of childbearing potential and women of non childbearing potential (defined as at least 2 years postmenopausal or permanently sterilized women \[bilateral tubal ligation, bilateral ovariectomy, or hysterectomy\]) must have a negative serum pregnancy test at screening or pretreatment on Day 1.
• The subject or a LAR has provided written informed consent.
• The subject or the LAR is aware of the investigational nature of this study and willing to comply with protocol treatments, and other evaluations listed in the ICF.

You may not qualify if:

• Participation in any other clinical trial of an experimental treatment for COVID-19 or participation in another interventional clinical trial, including an expanded access trial.
• Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS CoV 2 infection \<24 hours prior to study drug dosing except for remdesivir.
• Uncontrolled hypertension (systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>100 mmHg), unstable angina, congestive heart failure of any New York Respiratory Association classification, serious cardiac arrhythmia requiring treatment (exceptions: atrial fibrillation, paroxysmal supraventricular tachycardia), or history of myocardial infarction within 12 months of enrollment.
• Hypotension requiring vasoactive peptides, such as dopamine, norepinephrine, epinephrine, or dobutamine.
• Renal function impairment (creatinine clearance \[Cr. Cl.\] \<50 mL/min, based on Modification of Diet in Renal Disease calculation).
• Liver function impairment
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>5 × upper limit of normal (ULN), or ALT/AST \>3 × ULN plus total bilirubin \>2 × ULN.
• Total bilirubin \>1.5 × ULN, unless the subject has known Gilbert's syndrome.
• Platelet count \<50 000/µL
• Multi-organ failure.
• Document active infection with a bacterial pathogen requiring parenteral systemic antibiotics.
• Bacterial or fungal sepsis.
• History of live vaccination within the last 4 weeks prior to study enrollment; subjects must not receive live, attenuated influenza vaccine (eg, FluMist) within 4 weeks before enrolment or at any time during the study.
• History of an allergic reaction or hypersensitivity to the study drug or any component of the study drug formulation.
• Anti-inflammatory treatments other than steroids (eg, complement inhibitor, anti-GM-CSF antibody, anti-IL6 antibody) ARE PROHIBITED. However, antiviral drugs (eg, remdesivir,), systemic corticosteroids, and non steroidal anti inflammatory drugs (NSAIDs) ARE ALLOWED.

Sponsors & Collaborators

• Oncotelic Inc.: lead

Study Sites (1)

Praxis Pesquisa Medica S / S Ltda

Jardim, Brazil

Location

MeSH Terms

Conditions

COVID-19

Interventions

Trabedersen; artemisinin; Saline Solution

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Vuong Trieu, PhD

  Oncotelic Inc.

  STUDY DIRECTOR

Central Study Contacts

Federico Lerner, MD

CONTACT

54 (911) 2852.0457; federico@latinaba.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 16, 2021
• Study Start: April 1, 2021
• Primary Completion: August 1, 2021
• Study Completion: October 1, 2021
• Last Updated: March 16, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)